III Degree Hemorrhoids Clinical Trial
Official title:
Safety and Short Term Effectiveness of EEA Stapler vs PPH Stapler in the Treatment of III Degree Haemorrhoids. Prospective Randomized Controlled Trial
Stapled hemorrhoidopexy has gained wide acceptability among colorectal surgeons because of
less postoperative pain compared with excisional surgery, however a still relevant
percentage of postoperative bleedings and long-term hemorrhoid recurrence are reported. A
new stapler device has been designed to overcome these drawbacks by modifying the stapled
sutures and by increasing the space for mucosal resection in the case of the stapler.
This randomized controlled study was aimed to demonstrate whether the new EEA stapler
Covidien was able to resect more quantity of prolapsed mucosa than the traditional PPH 01/03
Ethicol Endosurgery by measuring the surface of the resected specimen and to demonstrate if
the modified stapled sutures can ensure better intraoperative hemostasis by measuring the
number of overstitches required to get perfect hemostasis during the operation.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment